21 C.F.R. § 803.13 Do I need to submit reports in English?
Title 21 - Food and Drugs
(a) Yes. You must submit all written or electronic equivalent reports required by this part in English. (b) If you submit any reports required by this part in an electronic medium, that submission must be done in accordance with §803.14.
Title 21: Food and Drugs
PART 803—MEDICAL DEVICE REPORTING
Subpart A—General Provisions
§ 803.13 Do I need to submit reports in English?
